BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM

    MDR report key: 4863767 · Received June 23, 2015

    Report

    Report Number
    3004753838-2015-22796
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 28, 2015
    Report Date
    May 28, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION AND DATA WAS NOT PROVIDED; THEREFORE, THE REPORTED COMPLAINT OF FIRMWARE ERROR CANNOT BE CONFIRMED. IT WAS REPORTED THAT A PEDIATRIC PATIENT WAS USING A RECEIVER APPROVED ONLY FOR ADULTS. IT SHOULD BE NOTED THAT THE DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM STATES: THE DEXCOM G4 SYSTEM IS NOT APPROVED FOR USE IN CHILDREN OR ADOLESCENTS, PREGNANT WOMEN OR PERSONS ON DIALYSIS. HOWEVER, A ROOT CAUSE FOR THE REPORTED FIRMWARE ERROR CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT CONFIRM THE REPORTED EVENT OF A FIRMWARE ERROR. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT THAT THE RECEIVER DISPLAYED A FIRMWARE ERROR ON (B)(6) 2015. PEDIATRIC PATIENT WAS USING ADULT RECEIVER. THE PATIENT'S MOTHER DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406804 DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22495-PNK 5198508

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR